or psychological examinations or tests” (45 C.F.R. § 46.102(j)). Research studies are evaluated according to whether they pose more risk than what people face when going about their normal activities. Most social and behavioral sciences research meets the definition of minimal risk. However, determining the ordinary risks of daily living is tricky. Such risks can vary depending on where people live, their health status, their jobs, and the kinds of activities in which they regularly engage.
Every research study can be considered to pose either “no more than minimal risk” or “greater than minimal risk.” As described in more detail in Part 8: Negotiating the IRB Review Process, the type of institutional review board (IRB) review (exempt, expedited, or full board) that a research study must undergo is determined by whether the research study is deemed by the IRB to pose no more than minimal risk or greater than minimal risk. A comprehensive IRB application should clearly outline risks and provide information to help the IRB make the appropriate determination.
Researchers and IRBs may not always be consistent in their interpretation and application of the concept of minimal risk, due to the broad regulatory definition. For example, whose daily life should be considered—a person who represents the majority of people in a community, or a person who represents people who will likely participate in the research? Either standard may be applied by an IRB.
More questions? See #16, #77, and #79.
Question #14 What Are the Potential Benefits of Research?
A research study should be conducted only if it offers some benefit to science and society: that is, it answers a new question or adds new information to what is already known. Research may also benefit those who participate. Different kinds of benefits may be offered to participants, and these should be described in the research protocol and during the consent process. In order to be ethical, research must always have potential for social or scientific benefit, but it does not have to directly benefit participants.
Some research studies provide tangible benefits, such as resources or services (related to the study’s primary objective) that participants normally would not be able to access (or easily access) outside of study participation. For example, a study on weight loss may provide participants with services such as a health screening or resources such as books, step counters, scales, exercise equipment, or pre-made meals. In describing benefits to participants during recruitment and the informed consent process, financial payment for research participation should not be considered as a tangible benefit.
Participants may also receive intangible benefits from participating in a research study. Participants may learn more about a specific health issue, enjoy interacting with others, or appreciate the opportunity to share their experiences and views. For example, individuals who participate in qualitative interviews about a traumatic experience (such as domestic violence or a natural disaster) may have a positive emotional response from talking about their experience. In addition, some participants may feel good about participating in research because it may help others in the future. Similarly, participants may also benefit psychologically from participating in research, knowing that they are contributing to science or helping researchers find solutions to social problems that affect their community.
Even when there is potential to benefit from a research study, not all participants may experience benefit. As a result, some participants may regret participating in the research. Researchers must take care when describing the benefits to participants not to exaggerate their value. A good rule to follow is to state clearly that participants may receive some benefits, and emphasize only those benefits that all participants have an opportunity to receive.
In research that aims to evaluate the effects of an educational or behavioral intervention, researchers should not promise benefits in the form of specific outcomes. Consider, for example, the study of an educational intervention that aims to improve reading scores among elementary school children. If the research demonstrates that the intervention is efficacious, some participants who received the experimental intervention will in fact have received a benefit from research participation, that is, improved reading scores. However, researchers should not promise that children’s reading scores will improve if they participate in the study because the real purpose of intervention research is to gather data to determine the efficacy or effectiveness of an intervention so that individuals in the future can benefit, not individuals in the study. And even the best interventions do not work for everyone who tries them. Further, intervention research often includes a control group, which means that only some participants receive the experimental intervention, and others receive a placebo or no intervention—and therefore the likelihood of any benefit is low for those in the control group.
Research can offer benefits not only to those who participate, but also to the community in which the research is conducted. Such benefits can be tangible, such as paid employment opportunities, or intangible, such as development of research capacity. All kinds of research, regardless of the findings, ideally benefits science and society. For example, surveys, interviews, and ethnographic studies can identify root causes or correlational factors for social problems. Or, if an intervention is shown to be efficacious, it can be offered widely to benefit other individuals in the community and elsewhere. If the intervention is shown not to be efficacious, science still benefits because researchers can rule out what does not work; society benefits because citizens will not be offered (and their tax dollars will not pay for) programs that do not work.
More questions? See #15, #16, and #62.
Question #15 How Do I Design My Research So That the Risk–Benefit Balance Is Favorable?
The federal research regulations require that institutional review boards (IRBs) determine that the “[r]isks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result” (45 C.F.R. § 46.111(2)) from the research. This means that participants should not be subjected to risks when participating in research without the prospect of some benefit. Research does not have to provide direct benefits to those who participate, but there must be some potential benefit to science and society.
While there is no magic formula for determining a reasonable balance between research risks and potential benefits, you must honestly consider the following:
the anticipated risks of study participation;
the likelihood and magnitude of those risks, and steps you will take to minimize those risks;
the potential expected benefits of the research to participants; and
the potential knowledge that will be gained by your study.
When designing your research study, you will want to make sure you have clearly thought through all these issues and that, from your perspective, the potential benefits outweigh the risks. You will also want to ensure that this information is clearly described in your protocol, so the IRB has sufficient knowledge to make their determination. It is important to keep in mind that IRBs may view the risks and benefits of a particular study differently from the researcher who designed the study. Perceptions of risks and benefits may also vary among the different members of an IRB.
More questions? See #11, #12, and #14.
Question #16 How Do I Make Sure That Participants in My Research Do Not Overestimate the Benefits or Underestimate the Risks?
The term “therapeutic misconception” is used to describe when research participants incorrectly assume that they will directly benefit from taking part in a research study. However, the primary purpose of research is to gather generalizable
